FDA red and green lights: March 2026

March saw four FDA approvals in oncology, the most notable of which was a green light for Johnson & Johnson’s Tecvayli/Darzalex combo in second-line-plus multiple myeloma. This marks the second cancer approval under the new US commissioner’s national priority voucher (CNPV) programme.

A more surprising green light came for Corcept’s relacorilant, now branded Lifyorli, as part of an Abraxane combo in post-Avastin ovarian cancer. The drug received a complete response letter in Cushing’s syndrome in December, with regulators flagging liver toxicity concerns, but this didn’t appear to be an issue in oncology.

Meanwhile, Bristol Myers Squibb’s Opdivo expanded its reach again, into first-line stage III or IV classical Hodgkin lymphoma, alongside chemo.

And Lantheus managed to salvage something from its deal with Point Biopharma, with tentative approval of PNT2003 under the generic pathway. The SSTR2-targeting radiopharmaceutical is classed as a radioequivalent version of Novartis’s Lutathera. Still, other assets being developed by Point, which was acquired by Lilly in 2023 for $1.4bn, have fallen by the wayside.

Priority scheme

Tecvayli plus Darzalex was approved for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

The decision was backed by impressive data from the Majestec-3 trial, which spurred the FDA proactively to award the combo a CNPV in mid-December. The programmed is designed to speed up the review process.

The first green light under the scheme came in February for Boehringer Ingelheim’s HER2 inhibitor Hernexeos in February in first-line HER2-mutant lung cancer; the drug previously had accelerated approval in second-line disease.

Separately, Tecvayli monotherapy just bagged a win in another second-line multiple myeloma setting, this time post-Darzalex, in the Majestec-9 trial. Full results have yet to be reported, and J&J doesn’t appear to have filed in the US, although it has disclosed an EU submission.

Zynyz CRL

Meanwhile, in late February Incyte slipped out news of a complete response letter for its anti-PD-1 antibody Zynyz in an SEC filing. The group had hoped to get the go ahead for a chemo combo in first-line NSCLC.

However, the supporting Pod1um-304 trial compared Zynyz plus chemo versus chemo alone, rather than versus Keytruda, raising questions about the ethics of the study and Zynyz’s chances of approval here. There were also doubts about the trial's generalisability to a US population.

Still, Incyte’s SEC filings didn’t refer to any of these issues, instead saying the CRL cited inspection findings at Catalent’s infamous Indiana facility. The company added that it was hoping to resubmit its supplemental BLA.

Selected March 2026 US regulatory decisions in oncology

Note: CNPV=commissioner’s national priority voucher. Source: OncologyPipeline.